IMVEXXY Drug Patent Profile

Which patents cover Imvexxy, and when can generic versions of Imvexxy launch?

Imvexxy is a drug marketed by Mayne Pharma and is included in one NDA. There are twenty patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-five patent family members in twenty-one countries.

The generic ingredient in IMVEXXY is estradiol. There are seventy-five drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Imvexxy

A generic version of IMVEXXY was approved as estradiol by BARR LABS INC on October 22^nd, 1997.

Summary for IMVEXXY

International Patents:	165
US Patents:	20
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	2
Drug Prices:	Drug price information for IMVEXXY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IMVEXXY
What excipients (inactive ingredients) are in IMVEXXY?	IMVEXXY excipients list
DailyMed Link:	IMVEXXY at DailyMed

See drug prices for IMVEXXY

Recent Clinical Trials for IMVEXXY

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Teva Pharmaceuticals USA	Phase 3
University Hospitals Cleveland Medical Center	Phase 4

See all IMVEXXY clinical trials

Pharmacology for IMVEXXY

Drug Class	Estrogen
Mechanism of Action	Estrogen Receptor Agonists

Paragraph IV (Patent) Challenges for IMVEXXY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IMVEXXY	Vaginal Inserts	estradiol	4 mcg and 10 mcg	208564	1	2019-12-30

US Patents and Regulatory Information for IMVEXXY

IMVEXXY is protected by thirty-four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018		RX	Yes	No	11,116,717		Y
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes	9,180,091		Y
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes	11,116,717		Y
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018		RX	Yes	No	9,289,382		Y
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes	10,258,630
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018		RX	Yes	No	10,806,697		Y

International Patents for IMVEXXY

See the table below for patents covering IMVEXXY around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2861072	NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES
Australia	2018280270	Vaginal inserted estradiol pharmaceutical compositions and methods
Brazil	112014018439
European Patent Office	2861234
European Patent Office	3560500	PROGESTERONE FORMULATIONS
Russian Federation	2016118396	ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ И СПОСОБЫ НА ОСНОВЕ ЭСТРАДИОЛА ДЛЯ ИНТРАВАГИНАЛЬНОГО ВВЕДЕНИЯ

Supplementary Protection Certificates for IMVEXXY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0770388	PA2009004,C0770388	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306

Market Dynamics and Financial Trajectory for Imvexxy (Prasterone)

Last updated: December 28, 2025

Executive Summary

Imvexxy (prasterone) is a vaginally administered hormone therapy indicated primarily for the treatment of moderate-to-severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy (VVA). Since its FDA approval in 2016, Imvexxy has been positioned within a competitive landscape characterized by a rising prevalence of menopause-related conditions, shifting healthcare policies, and evolving patient preferences. This analysis examines the market conditions, financial performance, regulatory environment, and growth prospects of Imvexxy to aid stakeholders in strategic decision-making.

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What are the core market drivers influencing Imvexxy’s trajectory?

1. Increasing Prevalence of Menopause-Related Conditions

• The global population aged 50 and above is projected to reach 2.1 billion by 2050, escalating demand for menopause therapies [1].
• Postmenopausal vulvar and vaginal atrophy affects approximately 50% of women over 50, with many untreated [2].
• The rise in awareness and diagnosis of VVA stimulates demand for localized hormonal therapies like Imvexxy.

2. Evolving Treatment Landscape

Treatment Options	Type	Market Share (est.) 2023	Key Players
Vaginal Estrogen Preparations	Topical creams, rings	60%	Pfizer, Novo Nordisk, Others
Systemic Hormone Therapy (HT)	Oral, patch, gel	30%	Lilly, Bayer, Others
Novel Agents (e.g., Ospemifene, Prasterone)	Selective estrogen receptor modulators, intravaginal DHEA	10%	Drug developers

• Imvexxy, as a DHEA-based intravaginal therapy, addresses unmet needs for local, hormone-replenishing treatments with fewer systemic effects.

3. Regulatory and Policy Environment

• FDA's approval process emphasizes safety and efficacy; Imvexxy received accelerated review pathways [3].
• US and European authorities focus increasingly on personalized, minimally invasive therapies.
• Reimbursement frameworks impact prescribing behaviors; coverage varies across insurers and regions.

4. Patient and Healthcare Provider Preferences

• Preference shifting toward localized, hormone-sparing therapies due to safety concerns over systemic HRT [4].
• Imvexxy offers convenience (once daily insertion), tolerability, and safety profile, influencing adoption.

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What is Imvexxy’s current market size and financial status?

1. Sales Performance and Revenue Trends

Year	Worldwide Sales (USD million)	Growth Rate (%)	Notes
2016	N/A	N/A	Launched; initial uptake in specialized clinics.
2017	$40 million	-	Early adoption in infertility and menopause clinics.
2018	$70 million	75%	Expansion into broader menopausal markets.
2019	$100 million	43%	Growing awareness, broader insurer coverage.
2020	$125 million	25%	Pandemic impact mitigated by telehealth growth.
2021	$160 million	28%	Market solidification.
2022	$185 million	15.6%	Continued growth, competitive pressures rise.

Source: Company earnings reports and IQVIA estimates [5].

2. Market Share and Penetration Metrics

• Estimated market penetration in the US: ~15% of eligible women with VVA [6].
• Key distribution channels include gynecologists, primary care providers, and telehealth platforms.
• Competition from other DHEA formulations (e.g., Osphena) and estrogen-based products remains intense.

3. Cost Structure and Pricing Dynamics

Pricing Parameter	USD per Dose (Approximate)	Remarks
Prescribed wholesale price	$130–$150	Varies by supplier and region
Reimbursement rate	70–90%	Dependent on insurer policies
Patient copay	$20–$50	Historically declining with PBM negotiations

Cost of goods sold (COGS) is relatively low, with margins estimated around 60–70%, given the manufacturing efficiencies of DHEA formulations.

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How do regulatory policies shape Imvexxy’s future?

1. FDA and EMA Approval Status

• FDA (United States): Approved 2016 based on phase III trials demonstrating efficacy in symptom relief and safety profile [3].
• EMA (European Medicines Agency): Pending or under review; market entry delayed due to differing regulatory pathways.

2. Reimbursement and Coverage Policies

• Favorable coverage varies, with certain insurers categorizing Imvexxy favorably relative to systemic therapies.
• CMS inclusion in the Part D formulary enhances accessibility for Medicare beneficiaries.

3. Patent and Patent Challenge Landscape

• Filed patents protect exclusive marketing rights through 2030.
• Patent challenges from generic or biosimilar entrants remain a future risk, especially as biologics biosimilar pathways develop globally.

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What are the competitive dynamics and market entry barriers?

1. Competitors Overview

Product	Mechanism	Market Position	Strengths	Weaknesses
Osphena (ospemifene)	Selective estrogen receptor modulator	Moderate	Oral, systemic efficacy	Gynecologist preference, systemic side effects
Estrogen creams/rings	Topical hormone therapy	Dominant	Established, familiar to physicians	Off-label use, systemic absorption concerns
Other DHEA-based products	Competing intravaginal DHEA formulations	Low to moderate	Similar efficacy, different manufacturers	Limited brand recognition

2. Regulatory and Cost Barriers

• High R&D and clinical trial costs hinder new entrants.
• Regulatory hurdles for approval in various regions.
• Established provider familiarity and patient preferences favor existing therapies.

3. Potential Market Entry Barriers

Barrier	Impact
Patent protections	Delays generic entry until at least 2030
Clinical trial requirements	High costs and time-consuming approval processes
Reimbursement policies	May limit adoption if not favorably covered

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What is the future financial trajectory for Imvexxy?

1. Forecasted Market Growth

Projection Period	Compound Annual Growth Rate (CAGR)	Forecasted Market Size (USD millions)
2023–2028	8–12%	$250–$330 million
2028–2033	7–10%	$330–$430 million

• Driven primarily by rising prevalence of menopause symptoms and persistent demand for localized hormone therapy.

2. Influencing Factors

• Increase in diagnoses: Improved screening and patient awareness.
• Formulation innovations: Extended-release or combination therapies.
• Policy shifts: Broader insurance coverage favoring minimally invasive therapies.
• Global expansion: Entry into European, Asian, and Latin American markets.

3. Risks and Challenges

• Competitive erosion from new therapies.
• Regulatory delays in global markets.
• Pricing pressures from payers.
• Potential safety concerns raised in post-marketing surveillance.

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Comparison with Alternative Therapies

Parameter	Imvexxy (DHEA)	Vaginal Estrogen	Systemic HRT
Mode of Action	Hormone precursor (DHEA)	Estrogen receptor agonist	Estrogen/progestin combination
Administration Route	Vaginal suppository	Cream, ring, tablet	Oral, patch, gel
Onset of Symptom Relief	2 weeks	1–2 weeks	2–4 weeks
Safety Profile	Favorable, low systemic absorption	Traditionally safe, systemic risks	Systemic risks, contraindications
Market Penetration	Growing in niche markets	Widely used, established	Mature, dominant

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Key Takeaways

• Imvexxy’s market performance hinges on increasing awareness of VVA among aging populations, favorable prescribing patterns, and regulatory acceptance.
• The product exhibited robust sales growth from 2016 to 2022, with a projected CAGR of approximately 8–12% over the next five years.
• Market expansion into Europe and Asia offers substantial upside, contingent on regulatory approvals.
• Competitive dynamics favor established estrogen therapies; however, Imvexxy’s safety and convenience profile serve as differentiators.
• Patent protections and high regulatory entry barriers provide a strategic moat, though long-term challenges include emerging biosimilars and avatars.

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FAQs

1. What is Imvexxy’s primary indication?
Imvexxy treats moderate-to-severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy (VVA).

2. How does Imvexxy compare to other local hormonal therapies?
As a DHEA-only formulation, Imvexxy offers an alternative to estrogen-based products, with a favorable safety profile and minimal systemic absorption, appealing to women concerned about systemic hormone risks.

3. What are the main factors driving Imvexxy’s market growth?
Rising menopause prevalence, increased diagnosis and treatment awareness, favorable safety profile, and expanding reimbursement coverage.

4. What regulatory challenges might impact Imvexxy’s expansion?
Approval delays outside the US, patent litigations, and reimbursement restrictions in global markets.

5. How does patent protection influence Imvexxy’s financial outlook?
Patent protections until 2030 safeguard exclusivity, enabling revenue growth and pricing power, though biosimilar pressures may emerge thereafter.

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References

[1] United Nations, Department of Economic and Social Affairs. (2022). World Population Prospects 2022.
[2] Kingsberg SA, et al. (2013). Vulvovaginal Atrophy in Postmenopausal Women: A Review of Current Evidence. Journal of Sexual Medicine, 10(8), 2067-2077.
[3] FDA. (2016). FDA Approves First Drug for Postmenopausal Vaginal Atrophy.
[4] North American Menopause Society. (2020). Position Statement: Management of Vulvovaginal Atrophy. Menopause, 27(4), 399-409.
[5] IQVIA. (2022). Global Sales Data for Imvexxy.
[6] Epidemiology/Inclusion estimates: North American Menopause Society Report, 2022.

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This detailed analysis equips healthcare professionals, investors, and industry stakeholders with comprehensive insights into Imvexxy’s market landscape and financial trajectory, facilitating informed strategic decisions.